CLOUDBREAK-B (02592) Successfully Submits CBT-009 New Drug Clinical Trial Application to Drug Review Center

Stock News01-06

CLOUDBREAK-B (02592) announced that its wholly-owned subsidiary, ADS Therapeutics LLC (ADS USA), incorporated in Delaware, United States, has successfully submitted a new drug clinical trial application for the Group's core product CBT-009 to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). CBT-009 is a novel, non-aqueous atropine ophthalmic formulation independently developed by the Group for the treatment of myopia progression in children and adolescents aged 5 to 19. Compared to existing aqueous atropine eye drops, CBT-009 significantly enhances formulation stability, allowing for long-term storage at room temperature without the need for preservatives, thereby substantially improving patient compliance and user experience. The Company believes that the successful submission of the new drug clinical trial application to the CDE marks a significant milestone in the clinical development of CBT-009 in China, laying a solid foundation for the Group to advance to Phase III clinical trials in this important market. The Group will continue to closely monitor the review progress with the CDE and will issue further announcements in due course to inform the Company's shareholders and potential investors of relevant updates.

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